Argus ll Psychophysical Test System 014202

GUDID 00856264005417

Laptop computer that is connected to the Clinician Programming System. It can be used to run performance evaluation software.

Second Sight Medical Products, Inc.

Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator
Primary Device ID00856264005417
NIH Device Record Keyc308e75b-eff7-456e-898e-0dc766e29048
Commercial Distribution StatusIn Commercial Distribution
Brand NameArgus ll Psychophysical Test System
Version Model Number014202-002-R
Catalog Number014202
Company DUNS086470742
Company NameSecond Sight Medical Products, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856264005417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBFProsthesis,Retinal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-05-06

Devices Manufactured by Second Sight Medical Products, Inc.

10856264005322 - Argus II Retinal Prosthesis Retinal Tacks2023-05-18 The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina.
00856264005288 - Argus ll Rentinal Prosthesis Kit, Right Eye2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005295 - Argus ll Retinal Implant Kit, Right Eye2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005301 - Argus ll Retinal Implant Kit2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005318 - Argus ll Retinal Implant Kit2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005332 - Argus ll Video Processing Unit2018-07-06 The VPU is used to process the images from the video camera (on the Glasses) and convert the images into electrical stimulation
00856264005349 - Argus ll Glasses2018-07-06 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc
00856264005356 - Argus ll Glasses2018-07-06 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.